Fall 2010 issue

This wide-ranging article examines the reasons behind the relatively low number of commercialized diagnostic products in oncology. Catalyst President Nancy Bradish Myers comments on the potential impact of an upcoming guidance from FDA’s Center for Devices and Radiological Health. She also comments on FDA’s review of its 510(k) device approval process.

The Alliance for a Stronger FDA expresses concern that the new FY 2011 Continuing Resolution (CR) provides no additional funding for the FDA. The CR funds the federal government through December 3, 2010. The group will urge Congress to increase funding when it considers the next CR after Election Day.

“For FDA, this could mean a slowing of its efforts to provide for adequate food inspectors and reviewers looking at the safety and efficacy of innovative medical products,” said Nancy Myers, Vice President of the Alliance. “The headlines over the last several months, such as the massive recall of contaminated eggs, make clear we need to continue to support improved funding levels for the agency.”

She added: “If the agency is put in a situation that it cannot adequately meet modern day regulatory challenges in a timely manner, it may have both health consequences and cause unnecessary job losses here in the US.”

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This is fantastic news Proteus Team! Congrats to you and TennCare. As the importance of remote monitoring is realized- especially during and immediately following this COVID pandemic, TennCare will be seen as an early adopter. This will be an important…https://lnkd.in/erD_A2G

FDA continues working around the clock to combat the #COVID19 pandemic. Here is our latest update: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-april-14-2020

In @AISHealth, Catalyst’s Jeff Myers weighs in on the #SCOTUS 8-1 ruling of #CMS owing billions to health insurers in risk corridor funding, discussing while it’s mandated by law, the risk corridor program isn’t well designed to begin with. http://catalysthcc.com/2020/05/04/health-insurers-hail-scotus-ruling-in-risk-corridors-case/

In @thehill, Catalyst’s Jeff Myers argues it’s unlikely early #COVID19 treatments will have remarkably high efficacy, but it’s still worth making and having them be available options to combat the deadly #coronavirus. https://thehill.com/policy/healthcare/494936-race-for-coronavirus-vaccine-faces-early-challenges